Acetic Acid

Product NDC: 0338-0656
11-digit product format: 003380656
Labeler code: 0338
Product ID: 0338-0656_87782b03-c260-4e1d-b96e-8f5aa94411e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetic Acid
Dosage form: IRRIGANT
Route: IRRIGATION
Labeler: Baxter Healthcare Corporation
Application: NDA018523
Marketing category: NDA
Marketing start: 1982-02-19
Substance: ACETIC ACID
Active strength: 250 mg/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	ACETIC ACID, GLACIAL	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT		1982-02-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N018523-001	AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018523-001	ACETIC ACID 0.25% IN PLASTIC CONTAINER	250MG/100ML	SOLUTION / IRRIGATION, URETHRAL	AT	1982-02-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018523-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018523-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018523-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018523-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018523-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018523-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018523-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018523-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018523-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018523-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018523-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018523-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018523-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018523-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018523-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018523-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018523-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018523-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018523-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018523-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018523-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018523-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018523-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018523-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018523-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018523-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018523-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018523-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018523-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018523-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018523-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018523-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018523-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018523-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018523-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018523-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018523-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018523-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018523-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018523-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetic Acid
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETIC ACID	250 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q40Q9N063P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307707	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
41bc12af-fac5-4ac1-b907-dcb3e35a054c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-0656-04	Acetic Acid	1000 mL in 1 BOTTLE, PLASTIC	IRRIGANT	1000		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0656-04	ML - Milliliter	0338-0656	97e93639-1e88-4893-a8be-d1423c817a2a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETIC ACID	ACTIVE INGREDIENT	Q40Q9N063P	ACETIC ACID IRRIGANT [BAXTER HEALTHCARE CORPORATION]	4
ACETIC ACID	ACTIVE MOIETY	Q40Q9N063P	ACETIC ACID IRRIGANT [BAXTER HEALTHCARE CORPORATION]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETIC ACID IRRIGANT [BAXTER HEALTHCARE CORPORATION]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0656	ACETIC ACID IRRIGANT [BAXTER HEALTHCARE CORPORATION]	12	Current NDC, Legacy NDC, 1 package rows	20250213_41bc12af-fac5-4ac1-b907-dcb3e35a054c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetic Acid	ACETIC ACID	Baxter Healthcare Corporation	41bc12af-fac5-4ac1-b907-dcb3e35a054c	2018-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018523 application number: NDA018523 ndc (product): 0338-0656

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q40Q9N063P	ACETIC ACID	64-19-7	ACETIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307707	acetic acid 0.25 % Irrigation Solution	PSN	41bc12af-fac5-4ac1-b907-dcb3e35a054c	13
307707	acetic acid 2.5 MG/ML Irrigation Solution	SCD	41bc12af-fac5-4ac1-b907-dcb3e35a054c	13
307707	acetic acid 0.25 % Irrigation Solution	SY	41bc12af-fac5-4ac1-b907-dcb3e35a054c	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-0656-04	00338065604	1000 mL in 1 BOTTLE, PLASTIC (0338-0656-04)	1000 ml	1982-02-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0.25% Acetic Acid Irrigation, USP in Plastic Pour Bottle	Baxter Healthcare Corporation	2018-02-02	HUMAN PRESCRIPTION DRUG LABEL	13